IGKX0604MNXX104 |
IGKX1001BBXX101 |
IGKX1001BBXX102 |
IGKX1004BBXX101 |
IGKX1004BBXX102 |
IGKX1004BBXX108 |
capsule filters, filters, VGKX
- High Flow Rates
- High Throughput
- Very High Retention
- Low Protein Binding
- Compact Design
- Precipitate removal post viral inactivation
- Pre-filtration of serum solutions
- Clarification of cell harvest supernatants
- Polishing of turbid solutions
Construction |
Membrane |
Hydrophilic PES |
Pore size |
0.1µm, 0.2µm, 0.5µm |
Prefilter Membrane |
Microglassfiber |
Support Layers |
Polyester |
Body and Core |
Polypropylene |
Size |
Size |
|
Effective Filtration Area (Nominal) |
|
Operational |
Max. Operating Temperature |
|
Max. Differential Pressure |
75 Psi (5 Kg/cm²)@ 25 °C | 42 Psi (3 Kg/cm²) @ 30 °C |
|
Burst Pressure |
>8 Kg/cm² |
Sterilization By Gas |
Sterilizable by Ethylene Oxide |
Sterilization By Autoclave |
Autoclavable at 125°C for 30minutes, 25 cycle and it cannot be In-line steam sterilized |
Shelf Life |
3 years after EO sterilization |
Assurance |
Toxicity |
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics |
Bacterial Endotoxin |
Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test |
Bioburden |
Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 |
Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 210.3 (b)(6) for fiber release |
Particle Release |
The filtrate complies with USP <788> test for particulate matter in injections |
Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices |
Oxidizable Substances |
Within limits as specified in USP |
Quality Management System |
ISO-9001 Certified |
USFDA |
DMF No. 015554 |
ClariPro® GK- 25mm
| | Pore Size | Pore Size
| Code | 0.1µm | 36 | 0.2µm | 01 | 0.5µm | 04 | | I/O Connection | Connection | Code | Female Luer Lock | M | Male Luer Slip | N | ⅛" Hose Barb | H
| ¼" Hose Barb | B | | | | Sterility | | Code | Non Sterile | 1 | EO Sterile | 2 | | Pack Size | Pack Size | Code | 100 | 04 | |
Example :
Example for Non Sterile: IGKX0604MNXX104 Example for EO Sterile: IGKX0604MNXX204
ClariPro® GK- 50mm
Type | ClariPro® GK (with vent)
| VGKX | ClariPro® GK (without vent)
| IGKX | | | Pore Size | Pore Size
| Code | 0.1µm | 36 | 0.2µm | 01 | 0.5µm | 04 | | I/O Connection | Connection | Code | ¼” SHB | B* | ¾" Sanitary Flange* | S* | Female Luer Lock** | M** | | | | Sterility | | Code | Non Sterile | 1 | EO Sterile | 2 | | Pack Size | Pack Size | Code | 10 | 02 | |
*¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only
**Female luer lock is available in filters without vent only
Example for Non Sterile: VGKX1004BBXX102 Example for EO Sterile: VGKX1004BBXX202